Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

NCT01719952 | Completed DMC

• 1 other identifier: UKMMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013. The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS). Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.

Conditions

Pregnancy Related; Anaesthesia

Keywords

pregnancy; anaesthesia; caesarean section

Outcome Measures

Primary Outcomes (1)

• Haemodynamic effects

  1. Haemodynamic effect (blood pressure, heart rate, saturation of oxygen) 2. Presence of ECG changes such as ST depression and changes in T-waves 3. Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain) 4. To compare the troponin T levels

  2 years

Secondary Outcomes (1)

• Blood loss measurement

  2 years

Study Arms (2)

Carbetocin

EXPERIMENTAL

Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal

Drug: Carbetocin

Oxytocin

ACTIVE COMPARATOR

Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.

Drug: Oxytocin

Interventions

Carbetocin DRUG

IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group. pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.

Also known as: Duratocin for carbetocin, pitocin for oxytocin

Carbetocin

Oxytocin DRUG

5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.

Also known as: pitocin

Oxytocin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS.
• Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby.
• Ability to provide informed consent.

You may not qualify if:

• Emergency caesarean section
• Preterm Labour
• Grandmultipara
• Multiple Pregnancy
• Placenta Previa
• Previous PPH
• Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2))
• Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder.
• Contraindication to carbetocin and oxytocin
• Language Barrier
• Women undergoing general anaesthesia
• Women who has abnormal baseline ECG that suggestive myocardial ischemia

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Department of O&G

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Interventions

carbetocin; Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nirmala C Kampan, MRCOG(UK)

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MRCOG(UK)

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 27, 2015

Record last verified: 2015-02

Locations

MY (1)